Enabling safe, intuitive, connected medical devices.As populations age and health care costs come under ever more scrutiny, innovations in medical device design can be a defining differentiator in the market place. For over 30 years, the QNX Neutrino RTOS has been providing a full featured, multi-core operating system that exceeds the most demanding requirements for reliability, performance and data safety & security. With QNX’s field-proven portfolio of pre-integrated technologies, solutions, certification services and a broad partner ecosystem, developers can focus on application design and functionality.
QNX Software Systems has significant presence in the healthcare industry with a platform that enables highly reliable, available, connected, and secure medical devices, including:
- Blood analyzers to test blood samples
- Pulse oximeters to measure the oxygen saturation of a patient's blood
- Handheld CTG monitoring units to monitor babies'' heart rate
- Angiography to visualize blood vessels
- Diagnostic equipment
- Patient monitoring units to monitor vital signs
- Anaesthesia monitoring devices
- CardioQ hemodynamic monitoring systems to evaluate heart performance
- Hemodynamic cardiac/pulse monitors
- Retinal scanning devices
- High-performance lasers for eye surgery
- Electrocardiograph stress test equipment
Core operating system
A real-time operating system can be a critical component of a safety-critical device, providing inherent security, reliability, and high-availability. The QNX Neutrino RTOS microkernel architecture incorporates core functionality into a tiny, well-tested kernel while leaving drivers, networking stacks, and other OS services outside in memory protected space –providing a high degree of determinism and fault-tolerance. Choosing the right RTOS partner can simplify certification processes, provide clear product differentiation and help to realize significant BOM and cost advantages.
Integrated development environment
The QNX Momentics Tool Suite is an Eclipse-based IDE that is tightly integrated with many sophisticated tools for debugging and optimizing code during different phases of the software development cycle. Innovative profiling tools provide insight into system and application behavior - facilitating code coverage testing, performance profiling, debugging, and source-level verification. Reusable software assets and industry standard tools allow for system scalability and portability both in the short term and down the road.
Graphics / HMI
QNX Software Systems provides one of the industry’s most comprehensive solutions for building intuitive, high-resolution graphical displays. QNX supports today’s leading HMI technologies (Adobe Flash, HTML5, OpenGL ES, Open VG), hardware acceleration, and a wide range of graphics platforms. We also offer a set of tools and runtime components for creating sophisticated displays that feature accelerated 2D and 3D graphics rendering.
The middleware services layer of the QNX software architecture allows developers to separate application logic from the HMI layer. This facilitates the rapid integration of multimedia codecs from a wide range of sources, including hardware-accelerated codecs for playback and recording of audio/visual media.
For patient-monitoring applications in portable medical devices that require a browser, QNX Software Systems supports Webkit.
For telehealth and remote monitoring QNX supports a tiny embedded HTTP 1.1 web server that supports CGI 1.1, authentication, and dynamic HTML.
Fault-tolerant file systems
QNX Software Systems supports a wide range of block and flash file system formats along with a power-safe disk file system for guaranteed data integrity and reliable storage. Our flash file system (FFS3), designed primarily for NOR flash, supports wear-leveling, error-handling, background reclaim, and fault recovery; our NAND flash file system (ETFS) offers wear-levelling and resists power failure corruption.
High availability is not optional for life-critical medical devices. The QNX framework provides critical process monitoring and restarts without the need to reboot, ensuring 100% device uptime.
Adaptive partitioning offers dynamic scheduling capabilities to enforce guaranteed service availability as well as optimizing device performance. This is particularly important when integrating third party software – which is often CPU intensive. By eliminating wasted, unused cycles created by fixed-partitioning designs, adaptive partitioning speeds time to market and does away with the complex task-starvation problems that typically arise during integration.
QNX Software Systems offers one of the most comprehensive networking solutions for an embeddable RTOS with capabilities typically reserved for desktops and servers. Our native distributed processing supports complex distributed systems in which multiple devices seamlessly share resources and communicate without custom protocols. Our networking ecosystem offers support for all forms of wireless networking from point-to-point connections such as Bluetooth and ZigBee to peer-to-peer networking like WiFi (802.11) – without compromising safety or security of sensitive patient data.
As outlined in the Health Insurance Portability Accountability Act (HIPAA) in the United States, patient data must be stored and transmitted in ways that maintain strict data privacy measures. QNX provides support for a number of authentication and security protocols including: WEP, WPA/WPA2, Radius, 802.1x, SSL, IPSec, IPv6, NAT, etc.
Safety, security, reliability and quality are essential for any medical device. All these values lie at the very core of the QNX software architecture; they also form the foundation for certifications - FDA, etc - critical to all the medical devices. To demonstrate its commitment to medical devices market, QNX Software Systems has undertaken several strategic certification programs. These programs help customers to concentrate on their innovation, reduce costs, improve time to market, and quality of software assets.
The QNX management system is certified to the internationally recognized ISO 9001:2008 standard. ISO is firmly established as the globally implemented standard for providing assurance about the ability to satisfy customer requirements and enhance satisfaction. Auditors have evaluated and then certified the processes and systems governing the design & development of QNX software, as well as the provision of related support services.
ISO is the world's leading developer of voluntary, consensus-based international standards. There are more than 16,500 current ISO standards and related documents that specify the requirements for state-of-the-art products, services, processes, materials and systems, and for good conformity assessment, managerial and organizational practice.
IEC 62304 Software Life-Cycle for Medical Devices
The QNX Neutrino RTOS for medical devices is compliant with the requirements of International Electrotechnical Commission (IEC) standard 62304 Software Life-Cycle for Medical Devices. IEC 62304 is an international standard that provides a framework of life cycle processes with activities and tasks, and incorporates risk management requirements as outlined in IEC 14971.
IEC 61508 Safety Integrity Level 3 (SIL 3)
The QNX Neutrino RTOS Safe Kernel is certified to meet the requirements of International Electrotechnical Commission (IEC) standard 61508 Safety Integrity Level 3 (SIL3). IEC 61508 is an international standard for the functional safety of electronic systems, and offers a very high level of reliability and risk reduction when used in safety-critical systems for transportation, energy generation, process control, and other industries. Meeting the IEC 61508 requirements involves a systematic assessment by an independent certification body.
Common Criteria ISO/IEC 15408 Evaluation Assurance Level (EAL) 4+
The QNX Neutrino RTOS Secure Kernel is certified to meet the stringent requirements of the Common Criteria ISO/IEC 15408 Evaluation Assurance Level (EAL) 4+. The Target of Evaluation (TOE) includes not only the mature QNX Neutrino OS kernel, but also its multi-core (symmetric and bound multiprocessing) and secure partitioning technology. Certification to EAL 4+ validates that the security parameters claimed have been methodically tested by an independent lab and the certification authority (the Canadian Security Establishment (CSE)), and means that the QNX Neutrino secure kernel will exceed the assurance requirements required for EAL4.
The Common Criteria for Information Technology Security Evaluation is an international standard agreed to by the United States Government, Canada, and 23 other nations. It establishes standards for security functionality, security assurance, and security evaluation.
POSIX PSE52 Realtime Controller 1003.13-2003
The QNX® Neutrino® RTOS has been certified for conformance to the POSIX PSE52 Realtime Controller 1003.13-2003 System product standard, under the “POSIX: Certified by the IEEE and The Open Group” program. As a result, commercial customers and government agencies can choose QNX Neutrino with the assurance that it provides both the code portability and the realtime determinism needed for an array of military, networking, medical, and automotive systems. In addition to the functions covered in the PSE52 standard, QNX Neutrino supports many hundreds of other POSIX 1003.1 commands, utilities, and programming interfaces.
POSIX PSE52 certification also confirms QNX Software Systems’ commitment to the software defined radio (SDR) market, including the U.S. military’s Joint Tactical Radio System Software (JTRS) SDR program. PSE52 serves as a cornerstone of the Software Communications Architecture (SCA), the interoperability standard mandated by JTRS.
QNX Software Systems is certified conformant to the OpenGL ES standard. OpenGL® ES is a cross-platform API for full-function 2D and 3D graphics on embedded systems. QNX is also a contributing member of the Khronos Group, the industry consortium focused on the creation of open standard APIs to enable the authoring and playback of dynamic media on a wide variety of platforms and devices. QNX is active in the OpenGL® ES and OpenVG™ projects, which help bring accelerated 3D and 2D graphics to in-car computing devices, casino gaming applications, industrial control systems, and a variety of other embedded platforms.
With QNX, industrial customers have the assurance of using a software architecture proven in thousands of mission-critical and life-critical environments, including medical devices. In fact, QNX Software Systems has passed all audits by medical device companies seeking FDA approval for their QNX technology-based products.
See also: Certifications
QNX® Software Systems recognizes the importance of delivering pre-integrated solutions to meet the growing challenges faced by medical-device customers – regulatory burdens and unrealistic schedules, for example. As a result, the QNX partner ecosystem includes a wide range of processors, protocols (connectivity, security and networking), tools, and package solutions for building almost any reliable and safety-critical medical device.
QNX Professional Services provides the end-to-end services medical-device manufacturers need to develop highly reliable embedded software and meet regulatory agency requirements. Our services range from architectural reviews through software debugging and optimization to support for building rich HMIs.
IEC 61508 Certification Assistance
IEC 61508 certification was initially used in the automation and process-control industry but is now becoming popular in safety-critical medical devices. QNX Professional Services can help pave the path to certification through our IEC 61508 certification support service. By leveraging existing confidence-in-use (CIU) data on various QNX-supported hardware platforms and QNX expertise in IEC 61508 certification, our team can identify the best solution to shorten your time to certification and considerably reduce your costs at the system level.
HMI/Graphics Consulting Services
The need for a rich and compelling user experience is not an optional feature for many medical devices; the challenge for device vendors is to train their development teams to produce cutting-edge human-machine interface (HMI) solutions. The QNX Professional Services team has many years of experience designing, developing, and optimizing HMIs for various target platforms from a mix of technologies – Flash, HTML5 and native apps (Open GL ES and Open VG). This experience includes training engineering teams and building prototypes.
QNX Secure Kernel Extension Service
As remote access and connectivity become increasingly popular in medical devices, the challenge for device manufacturers is to keep transient patient electronic data secure. This however is becoming increasingly complex due to HIPAA regulatory requirements and the Common Criteria ISO/IEC 15408 EAL4+ certification, which is proving to be the standard of choice for security requirements. The QNX Neutrino RTOS 6.4 is certified to the stringent security requirements of the ISO/IEC 15408 EAL4+, which includes two hardware platforms (x86 with SMP and ARMLE). Recognizing the diversity of our customer base, we offer a range of services to help obtain the same certification on other versions of the QNX Neutrino RTOS, expand the scope of certification to include modules that are critical to your success, and incorporate new hardware platforms in your medical device certification.
FDA Consulting Service
QNX Software Systems has a proven track record of successfully helping companies with FDA approvals for devices running the QNX Neutrino RTOS, including FDA 510(k) clearance. Our professional services team can also provide product life-cycle management services — everything from process reviews to quality system audits. QNX also offers pre-qualified partners in our broad medical ecosystem to provide premarket notification services as well as the more complex premarket approval (PMA) process.